{"id":"F2021L00844","name":"National Health (Medication Program for Homeless People) Special Arrangement 2021","slug":"national-health-medication-program-for-homeless-people-special-arrangement-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101951,"registerId":"commonwealth-F2021L00844-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Simplified outline of this instrument","content":"#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Definition of homeless","content":"#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Application of this instrument","content":"#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.","sortOrder":6},{"sectionNumber":"Part 2","sectionType":"part","heading":"Special arrangement supplies of eligible pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":7},{"sectionNumber":"Division 1","sectionType":"division","heading":"Preliminary","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":8},{"sectionNumber":"8","sectionType":"section","heading":"Definition of special arrangement supply","content":"#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.","sortOrder":9},{"sectionNumber":"Division 2","sectionType":"division","heading":"Special arrangement supplies of eligible pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":10},{"sectionNumber":"9","sectionType":"section","heading":"Limited charges for supplies (no co‑payment)","content":"#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.","sortOrder":11},{"sectionNumber":"10","sectionType":"section","heading":"Value for safety net purposes for supplies","content":"#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.","sortOrder":12},{"sectionNumber":"11","sectionType":"section","heading":"No supply without prescription (continued dispensing)","content":"#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.","sortOrder":13},{"sectionNumber":"Division 3","sectionType":"division","heading":"Payment for special arrangement supplies of eligible pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":14},{"sectionNumber":"12","sectionType":"section","heading":"Payment for supply of benefits","content":"#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.","sortOrder":15},{"sectionNumber":"13","sectionType":"section","heading":"Claims for payment for supply of benefits","content":"#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.","sortOrder":16},{"sectionNumber":"Part 3","sectionType":"part","heading":"Administration","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":17},{"sectionNumber":"14","sectionType":"section","heading":"Organisations may apply for approval","content":"#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.","sortOrder":19},{"sectionNumber":"15","sectionType":"section","heading":"Decision on application","content":"#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.","sortOrder":20},{"sectionNumber":"16","sectionType":"section","heading":"Monthly reporting by approved organisations","content":"#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.","sortOrder":21},{"sectionNumber":"17","sectionType":"section","heading":"Secretary may request further information from approved organisations","content":"#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.","sortOrder":22},{"sectionNumber":"18","sectionType":"section","heading":"Approved organisations to supply information on request","content":"#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.","sortOrder":23},{"sectionNumber":"19","sectionType":"section","heading":"Nominating approved pharmacists","content":"#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.","sortOrder":25},{"sectionNumber":"20","sectionType":"section","heading":"Secretary may approve forms","content":"#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.","sortOrder":27},{"sectionNumber":"Division 4","sectionType":"division","heading":"Review of decisions","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Medication Program for Homeless People) Special Arrangement 2021.\n  (2) This instrument may also be cited as PB 73 of 2021.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 4 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of eligible pharmaceutical benefits to eligible homeless persons.\n\nThe eligible pharmaceutical benefits will be supplied by approved pharmacists and provided directly to eligible homeless persons or alternatively, through a representative from the approved not‑for‑profit organisation, who may act as an ‘agent’ on behalf of the eligible homeless person.\n\nThis instrument also deals with payments for these supplies and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 5 Definitions\n\n> Note: The expression Secretary used in this instrument is defined in the Act.\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approval number has the meaning given by subparagraph 15(1)(a)(ii).\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved organisation means an organisation for which an approval under section 15 is in force.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> concessional beneficiary has the same meaning as in Part VII of the Act.\n\n> eligible patient: a person is an eligible patient if:\n\n    (a) the person is a concessional beneficiary; and\n    (b) the person is homeless; and\n    (c) the person has a paper‑based prescription, or a repeat authorisation, for an eligible pharmaceutical benefit; and\n    (d) the person is unlikely to receive the benefit without assistance under this instrument because the person is incapable of managing the person’s affairs; and\n    (e) undesirable medical or social consequences are likely to occur if the person does not receive the benefit.\n\n> eligible pharmaceutical benefit means a pharmaceutical benefit, other than a pharmaceutical benefit that can only be supplied under Part VII of the Act:\n\n    (a) in accordance with a special arrangement under section 100 of the Act; or\n    (b) under the prescriber bag provisions.\n\n> Note: See sections 85AAA and 85AA of the Act.\n\n> homeless has the meaning given by section 6.\n\n> nominated pharmacist, for an approved organisation, means an approved pharmacist for which a nomination by the organisation is in effect under section 19.\n\n> not‑for‑profit entity means:\n\n    (a) an entity that is entitled to be registered under the Australian Charities and Not‑for‑profits Commission Act 2012; or\n    (b) a non‑profit body (within the meaning of the Electronic Transactions Act 1999).\n\n> paper‑based prescription has the same meaning as in the Regulations.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> prescriber bag provisions has the same meaning as in Part VII of the Act.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> repeat authorisation has the same meaning as in the Regulations.\n\n> special arrangement supply has the meaning given by section 8.\n\n> value for safety net purposes has the same meaning as in Part VII of the Act.\n\n#### 6 Definition of homeless\n\n  (1) A person is homeless if:\n    (a) the person does not have conventional accommodation; or\n    (b) the person moves frequently from one form of temporary shelter to another.\n\n> Note 1: For example, paragraph (a) covers persons living on the streets, sleeping in parks, squatting in derelict buildings or using cars or railway carriages for temporary shelter.\n\n> Note 2: For example, paragraph (b) covers persons using emergency accommodation (such as hostels for the homeless or night shelters), teenagers staying in youth refuges, and women and children escaping domestic violence (staying in women’s refuges).\n\n  (2) For the purposes of this instrument, a person is not homeless if the person is a care recipient of residential care within the meaning of the Aged Care Act 1997.\n\n#### 7 Application of this instrument\n\n  This instrument applies to a supply of an eligible pharmaceutical benefit that is made on or after 1 July 2021.\n\n## Part 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 8 Definition of special arrangement supply\n\n  A supply of an eligible pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is:\n    (a) for supply to an eligible patient; and\n    (b) supplied by a nominated pharmacist for an approved organisation; and\n    (c) supplied on the basis of a paper‑based prescription, or a repeat authorisation, that is annotated with the organisation’s approval number by:\n    (i) the approved organisation; or\n    (ii) in exceptional circumstances, the nominated pharmacist as authorised by the approved organisation.\n\n### Division 2—Special arrangement supplies of eligible pharmaceutical benefits\n\n#### 9 Limited charges for supplies (no co‑payment)\n\n  Subsection 87(2) of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n#### 10 Value for safety net purposes for supplies\n\n  (1) The value for safety net purposes of a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect despite section 17A of the Regulations.\n\n#### 11 No supply without prescription (continued dispensing)\n\n  Section 89A of the Act does not apply to a special arrangement supply of an eligible pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of eligible pharmaceutical benefits\n\n#### 12 Payment for supply of benefits\n\n  (1) An approved pharmacist who has made a special arrangement supply of an eligible pharmaceutical benefit for an eligible patient is, subject to section 99AAA of the Act and to the conditions determined under section 98C of the Act and applicable at the time of the supply, entitled to be paid by the Commonwealth an amount that is equal to the amount that the patient could have been charged for the supply under paragraph 87(2)(a) of the Act if section 9 of this instrument did not apply to the supply.\n  (2) This section has effect in addition to section 99 of the Act.\n\n#### 13 Claims for payment for supply of benefits\n\n  (1) A claim for payment of an amount to which an approved pharmacist is entitled under section 12 in respect of a special arrangement supply of an eligible pharmaceutical benefit must include the approval number of the approved organisation annotated on the prescription or repeat authorisation for the supply.\n  (2) This section has effect in addition to section 99AAA of the Act.\n\n## Part 3—Administration\n\n### Division 1—Approved organisations\n\n#### 14 Organisations may apply for approval\n\n  (1) An organisation may apply to the Secretary to be approved for the purposes of this instrument.\n  (2) The application must:\n    (a) be made in writing; and\n    (b) include one or more nominations of approved pharmacists under section 19; and\n    (c) be made in the form (if any) approved under section 20.\n\n#### 15 Decision on application\n\n  (1) If the Secretary receives an application in accordance with section 14 to approve an organisation, the Secretary must, as soon as is reasonably practicable:\n    (a) if the Secretary is reasonably satisfied of the matters mentioned in subsection (2):\n    (i) approve the organisation; and\n    (ii) allocate a unique number (the organisation’s approval number) to the organisation; or\n    (b) otherwise—refuse the application.\n  (2) For the purposes of paragraph (1)(a), the matters are as follows:\n    (a) the organisation is a not‑for‑profit entity;\n    (b) the organisation has a function of providing care to homeless people;\n    (c) the organisation is not an approved pharmacist or an approved hospital authority;\n    (d) were the organisation to be approved, the organisation would assist eligible patients to receive special arrangement supplies of eligible pharmaceutical benefits in accordance with this instrument.\n  (3) The Secretary must give the organisation notice in writing of:\n    (a) the decision; and\n    (b) the date the decision takes effect; and\n    (c) if the decision was to approve the organisation—the organisation’s approval number.\n\n#### 16 Monthly reporting by approved organisations\n\n  (1) Within 14 days after the end of a month, an approved organisation must give the Secretary a report of the total number of prescriptions and repeat authorisations presented by the organisation to nominated pharmacists for the organisation for special arrangement supplies of eligible pharmaceutical benefits in the month.\n  (2) The report must be made:\n    (a) in writing; and\n    (b) in the form (if any) approved under section 20.\n\n#### 17 Secretary may request further information from approved organisations\n\n  (1) The Secretary may, in writing, ask an approved organisation to give the Secretary further information in relation to prescriptions and repeat authorisations mentioned in section 16.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 18 Approved organisations to supply information on request\n\n  If an approved organisation receives a request for information under section 17, the organisation must comply with the request by the day specified in the request.\n\n### Division 2—Nominated pharmacists\n\n#### 19 Nominating approved pharmacists\n\n  (1) An organisation may nominate an approved pharmacist for the purposes of making special arrangement supplies of eligible pharmaceutical benefits only if the approved pharmacist would be able to:\n    (a) ensure that prescriptions and repeat authorisations for such supplies are annotated with the organisation’s approval number; and\n    (b) maintain records of the value for safety net purposes of such supplies; and\n    (c) make such supplies in urgent circumstances.\n  (2) A nomination under this section must:\n    (a) be included in an application under section 14; or\n    (b) be made to the Secretary:\n    (i) in writing; and\n    (ii) in the form (if any) approved under section 20.\n\n### Division 3—Approved forms\n\n#### 20 Secretary may approve forms\n\n  The Secretary may, in writing, approve a form for the purposes of a provision of this instrument.\n\n### Division 4—Review of decisions\n\n#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":28},{"sectionNumber":"21","sectionType":"section","heading":"Internal review of decisions","content":"#### 21 Internal review of decisions\n\n  Application for review\n  (1) A person who is affected by a decision of the Secretary under this instrument may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made in the form (if any) approved under section 20; and\n    (c) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":29}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument stays within the original, narrowly stated purpose: it establishes a time‑limited administrative arrangement to facilitate supply of PBS medicines to homeless concessional beneficiaries through approved not‑for‑profit organisations and nominated pharmacists. It does not add unrelated powers or substantially broaden the range of beneficiaries or medicines beyond the defined eligible classes; rather it creates procedural rules (approvals, annotations, reporting, payments) to implement that specific purpose. (See sections 4, 5, 8–15)"},"complexity_factors":["About 21 operative sections (1–21) with a focused administrative scheme","Approximately 20 defined terms in the interpretation/definitions (section 5)","Multiple cross‑references to Part VII of the National Health Act 1953 (notably ss 87(2), 89A, 98C, 99, 99AAA, 100) and to the National Health (Pharmaceutical Benefits) Regulations 2017 (e.g. s17A) — requires reading those provisions to understand full effect","Conditional eligibility test with five conjunctive criteria for an eligible patient (section 5)","Discretionary approval standard for Secretary (\"reasonably satisfied\") and internal review process (sections 15, 21) — introduces administrative discretion","Several fixed deadlines and reporting rules: monthly reporting within 14 days, information request compliance at least 28 days (sections 16–17)","Narrow technical exclusions and exceptions (continued dispensing excluded, prescriber bag provisions exclusion) which require cross‑checking other instruments (sections 5, 11)","Claims and recordkeeping requirements tying together annotations on paper prescriptions, approval numbers and reimbursement (sections 8, 13, 19)"],"plain_english_summary":"**What this instrument does (mechanics)\n\n- Creates a limited, administratively‑managed program that lets approved not‑for‑profit organisations and nominated community pharmacists supply subsidised (PBS) medicines to certain homeless people without charging the usual patient co‑payment. (see sections 8–13)\n\n- Defines who is eligible: the person must be a concessional beneficiary, be homeless (as defined), hold a paper prescription or repeat authorisation for an eligible medicine, be unlikely to manage getting the medicine without help, and face likely undesirable medical or social consequences if they don't get it. (see section 5)\n\n- Requires that the prescription or repeat authorisation be annotated with the approved organisation’s unique approval number before the pharmacist supplies the medicine (the organisation may annotate it, or in exceptional circumstances the nominated pharmacist can if authorised). Such a supply is a \"special arrangement supply.\" (see section 8)\n\n- Removes the usual concessional patient charge for these supplies (so the patient is not asked to pay). The instrument then entitles the supplying pharmacist to be paid by the Commonwealth an amount equal to the co‑payment the patient would otherwise have paid. Pharmacists must include the organisation’s approval number on their claim. (see sections 9, 12, 13)\n\n- Treats the notional co‑payment amount as the value that counts for PBS safety‑net purposes for the patient. (see section 10)\n\n- Prohibits using the continued‑dispensing (supply without a script) provisions for these special arrangement supplies. (see section 11)\n\n- Establishes an approval and oversight regime for participating organisations: not‑for‑profit organisations that provide care to homeless people may apply to the Secretary for approval; the Secretary issues a unique approval number if satisfied with certain matters. Approved organisations must nominate pharmacists, report monthly on the number of prescriptions/repeat authorisations presented, and respond to information requests. Nominated pharmacists must keep records and be able to supply in urgent circumstances. The Secretary may approve forms and conduct internal reviews of decisions. (see sections 14–21)\n\n\nWho it affects\n\n- Eligible patients: concessional PBS beneficiaries who are homeless and meet the extra vulnerability criteria in section 5 (they must have a paper prescription or repeat authorisation and be unable to manage without help). (see section 5)\n- Not‑for‑profit organisations that provide care to homeless people and choose to administer the program through nominated pharmacists; they must apply for approval and comply with reporting and information requests. (see sections 14–18)\n- Community pharmacists who are nominated: they will supply medicines without charging the patient and claim reimbursement from the Commonwealth, subject to normal PBS payment conditions. (see sections 19, 12)\n- The Commonwealth budget: it reimburses pharmacists the co‑payment amount for each qualifying supply. (see section 12)\n\n\nWhy it matters (stated purpose, then practical trade‑offs)\n\n- Official purpose (stated): to remove immediate cost and logistical barriers for certain homeless concessional beneficiaries to obtain PBS medicines by enabling approved organisations to act as intermediaries and by removing the patient co‑payment. (see Simplified outline and sections 8–13)\n\n- Practical effects and implementation trade‑offs:\n  - Who pays: the Commonwealth pays the pharmacist the amount the patient would otherwise have paid (the notional co‑payment). That shifts the immediate out‑of‑pocket cost from patient to taxpayer while keeping the usual PBS subsidy structure otherwise intact. (see section 12)\n  - Who decides: the Secretary controls entry (approval numbers), reporting forms and information requests, and can review administrative decisions — giving the Department operational control over which organisations participate and how the program is documented. (see sections 15, 20, 17, 21)\n  - Behaviour change for providers: nominated pharmacists must annotate and record supplies, accept organisation‑presented scripts, and make urgent supplies when needed; organisations must manage prescriptions, nominate pharmacists and submit monthly counts. This creates administrative work for charities and pharmacies. (see sections 8, 14, 16, 19)\n  - Incentives and costs: pharmacists are reimbursed the patient charge, so they do not lose the usual co‑payment income; organisations take on coordination and reporting costs; the Commonwealth incurs additional expenditure equal to the accumulated notional co‑payments. (see sections 9, 12, 16)\n  - Compliance and verification risks: the Secretary’s approval and monthly reporting aim to limit misuse, but the instrument relies on paper prescriptions, annotation with approval numbers, and downstream record‑keeping to verify eligibility — creating potential frictions and verification burden. (see sections 8, 13, 16–18)\n  - Limits on substitution and scope: medicines that can only be supplied under other special arrangement or prescriber bag provisions are excluded; continued dispensing (temporary supply without a prescription) is excluded, so the program cannot be used as a backdoor for unscripted supply. (see section 5 definition of \"eligible pharmaceutical benefit\" and section 11)\n\n\nCompliance and administrative burden (concrete)\n\n- Approved organisations must apply in writing, nominate pharmacists, obtain an approval number, report monthly (within 14 days after month end) the total number of prescriptions/repeats presented, and respond to any Secretary information requests within at least a 28‑day window. (see sections 14–18)\n- Pharmacists must ensure prescriptions are annotated with the approval number, keep records of value for safety‑net calculation, and include the approval number on claims to the Commonwealth. (see sections 8, 19, 13)\n\n\nNet description (who pays, who decides, what changes)\n\n- The Commonwealth pays nominated pharmacists the notional co‑payment for qualifying supplies. (see section 12)\n- The Secretary (Department of Health) decides which not‑for‑profit organisations may participate and sets forms and information rules. (see sections 15, 20)\n- The program changes the flow of payment and paperwork: not‑for‑profits coordinate, pharmacists supply without charging the patient, and the Commonwealth reimburses pharmacists based on approved‑organisation annotations and claims. (see sections 8–13, 14–19)\n\n\nKey sections to read for implementers and auditors: sections 5 (eligibility definitions), 8 (definition of special arrangement supply), 9–13 (charges, safety net value, payment and claims), and 14–19 (approval, reporting and nominated pharmacists)."},"kimi_summary":{"_metrics":{"provider":"moonshot","completionTokens":2058},"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is the original 2021 instrument establishing the Medication Program for Homeless People. It remains tightly scoped to its original purpose: facilitating PBS access for homeless concessional beneficiaries through approved not-for-profit organisations. No evidence of scope creep beyond the initial policy intent."},"complexity_factors":["14 defined terms, most referencing external legislation (National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 2017)","5 cumulative criteria for 'eligible patient' (all must be satisfied: concessional beneficiary, homeless, holds prescription, incapable of managing affairs, risk of harm)","Hypothetical calculation mechanism for safety net purposes (calculating what the charge would have been if the waiver didn't apply)","Cross-references to 6 specific sections of the Act (sections 87, 89A, 98C, 99, 99AAA, 100) and 1 regulation (section 17A)","Exceptional circumstances provision allowing pharmacists (rather than organisations) to annotate prescriptions in limited cases","Layered approval structure: organisation approval → pharmacist nomination → monthly reporting"],"plain_english_summary":"This instrument creates a special scheme under the Pharmaceutical Benefits Scheme (PBS) to help homeless Australians access subsidised medicines when they cannot manage their own affairs.\n\n**Who it helps**\n- **Eligible patients**: People who are homeless (sleeping rough, in cars, or moving between emergency shelters), already hold a concessional card (like a Health Care Card), have a valid prescription, and are unable to manage their own medication without help. It also covers those where missing medication would cause serious health or social harm. People in residential aged care are excluded.\n\n**How it works**\n- **Approved organisations**: Not-for-profit groups (like homeless services, refuges, or outreach programs) apply to the Secretary for approval and receive a unique approval number.\n- **Nominated pharmacists**: These organisations partner with specific pharmacists who are approved to supply medicines under this arrangement.\n- **Acting as agent**: The organisation’s staff can act on behalf of the homeless person (the “agent”) to collect prescriptions and medications. The prescription is marked with the organisation’s approval number.\n\n**What it costs**\n- **Free for patients**: The usual PBS co-payment (the amount the patient normally pays) is waived—section 9 removes the charge entirely.\n- **Safety net protection**: Even though the patient pays nothing, the value of the medicine still counts toward their PBS Safety Net (the threshold where medicines become free for the rest of the year). The value is calculated as if the patient had paid the normal co-payment.\n- **No emergency supply**: Unlike normal PBS rules, pharmacists cannot use “continued dispensing” (supplying medicine without a prescription in an emergency) under this arrangement.\n\n**Paying pharmacists**\nThe Commonwealth pays the pharmacist an amount equal to what the patient would have paid as a co-payment, ensuring the pharmacy is not left out of pocket.\n\n**Administration and oversight**\n- Organisations must submit monthly reports on prescriptions handled.\n- The Secretary can request further information.\n- Decisions (like refusing approval) can be reviewed internally by the Secretary.\n\n**Why it matters**\nThis arrangement recognises that many homeless people face barriers—financial, cognitive, or practical—that stop them getting vital medicines. By allowing trusted community organisations to act as agents and removing the co-payment, it aims to prevent serious health deterioration in a highly vulnerable group."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021","history":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021/history","analysis":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021/analysis","conflicts":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021/conflicts","importantCases":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021/important-cases","documents":"/api/acts/national-health-medication-program-for-homeless-people-special-arrangement-2021/documents"}}